Oral Care in Non-Mechanically Ventilated Stroke Patients

Stroke, Ischemic Clinical Trial

Official title:

A Systematic Oral Care Protocol in Non-Mechanically Ventilated Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521659
• Other study ID #: Oral Care in Stroke
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to examine the effect of a systematic oral care protocol on bacterial colonization of the oral mucosa in non-mechanically ventilated stroke patients. This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times a day. The control group underwent non-standardized oral care, which is available in the routine practice of the clinic. Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity and complications.

Description:

This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times (at 06:00, 14:00, 22:00) a day (with use of an oral hygiene kit including chlorhexidin gluconate). The control group underwent usual care (oral care with use of the same kit but applied twice a day without following a protocol). Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity (by use of Oral Assessment Guide) and complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a diagnosis of stroke,
• Being not connected to a mechanical ventilator (patients who were on spontaneous breathing or receiving oxygen support with a mask or nasal cannula),
• Having at least 3 teeth, and
• Cannot meet the need for oral care.

Exclusion Criteria:

• Patients who were intubated or tracheostomized were excluded.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Standardized oral care protocol
Standardized oral care protocol (3 times a day at certain hours (06-14-22) with oral care set including chlorhexidine gluconate)

Locations

Country	Name	City	State
Turkey	Istanbul Bakirköy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari Egitim ve Arastirma Hastanesi /	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Bakirkoy Prof. Dr. Mazhar Osman Hospital for Psychiatry, Neurology and Neurosurgery

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chipps EM, Carr M, Kearney R, MacDermott J, Von Visger T, Calvitti K, Vermillion B, Weber ML, Newton C, St Clair J, Harper D, Yamokoski T, Belcher M, Ali N, Hoet AE, Van Balen J, Holloman C, Landers T. Outcomes of an Oral Care Protocol in Postmechanically Ventilated Patients. Worldviews Evid Based Nurs. 2016 Apr;13(2):102-11. doi: 10.1111/wvn.12124. Epub 2016 Jan 14. — View Citation

Emery KP, Guido-Sanz F. Oral care practices in non-mechanically ventilated intensive care unit patients: An integrative review. J Clin Nurs. 2019 Jul;28(13-14):2462-2471. doi: 10.1111/jocn.14829. Epub 2019 Mar 13. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of bacteria variable	The number of bacteria in the oral mucosa of stroke patients who are given oral care according to the standardized oral care protocol after the intervention will be less than the pre-intervention and control groups.	5 days.
Secondary	the type of bacteria variable	The type of bacteria in the oral mucosa of stroke patients who are given oral care according to the standardized oral care protocol after the intervention will be less than the pre-intervention and control groups.	Evaluation will be done at the beginning of the study and at the end of the 5th day.
Secondary	oral evaluation scale variable	The mean Oral Evaluation Scale score of stroke patients who are given oral care according to the standard oral care protocol after the intervention will be lower than the pre-intervention and control groups.	Evaluation will be done at the beginning of the study and at the end of the 5th day.